BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANCE CS2

    MDR report key: 5689497 · Received May 31, 2016

    Report

    Report Number
    2112667-2016-01044
    Event Type
    Malfunction
    Date Received
    May 31, 2016
    Date of Event
    May 2, 2016
    Report Date
    May 31, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K123125
    Removal / Correction Number
    SEE BLOCK H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON (B)(6) 2015. THE RECALL CLASSIFICATION NUMBER IS Z-0677-2016 THROUGH Z-0682-2016. PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON (B)(6)2015. THE RECALL CLASSIFICATION NUMBER IS Z-0677-2016 THROUGH Z-0682-2016.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING THE EXHALATION PHASE, ENDOTHORACIC PRESSURE WAS NOTED TO BE HIGHER THAN EXPECTED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342946 AVANCE CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1